BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCENT DR RF

    MDR report key: 4091410 · Received January 14, 2014

    Report

    Report Number
    2017865-2014-07804
    Event Type
    Malfunction
    Date Received
    January 14, 2014
    Date of Event
    May 12, 2011
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    DXY
    PMA / PMN Number
    NA
    Removal / Correction Number
    Z0429
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFO PROVIDED BY MFR, NO MEDWATCH FORM WAS RECEIVED. THIS HISTORICAL COMPLAINT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF COMPLAINT FILES IN RESPONSE TO A RECENT FDA INSPECTION. THERE IS NO CHANGE TO THE ACTUAL PERFORMANCE OF THE PRODUCT AND THIS REPORT ONLY REPRESENTS AN ENHANCEMENT TO THE REPORTING CRITERIA GOING FORWARD. FINAL ANALYSIS CONFIRMED THE PREMATURE BATTERY DEPLETION. DESPITE EXTENSIVE TESTING OF THE DEVICE AND BATTERY, THE ROOT CAUSE OF THE ANOMALY COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PULSE GENERATOR WAS INTERROGATED WHILE STILL IN THE BOX AND IT EXHIBITED A TELEMETRY ANOMALY AND PREMATURE BATTERY DEPLETION. THE DEVICE WAS NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34782 ACCENT DR RF IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST. JUDE MEDICAL, INC., CRMD PM2212

    Patients

    Seq Age Sex Outcome Treatment
    1